The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems:

BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
BD Multitest IMK Kit with or without BD Trucount Tubes .
BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems:

BD Multitest IMK Kit with or without BD Trucount Tubes .
BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .

For in vitro diagnostic use.

Device Description

The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.

The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BD FACS™ Sample Prep Assistant III, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Study/Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Accuracy	Demonstrate equivalent performance for sample preparation.	The SPA III with the BD FACSCalibur system demonstrated equivalent performance in its ability to prepare human whole blood for flow cytometric analysis.
Precision	System precision within specification.	The SPA III demonstrated system precision within specification.
Carryover	System carryover within specification.	The SPA III demonstrated system carryover within specification.

Important Note: The document does not explicitly state numerical acceptance criteria for accuracy, precision, or carryover. It refers to established guidelines (CLSI document EP9-A2 for Accuracy, CLSI document EP5-A2 for Precision, and Class II Special Controls Guidance Document for Carryover) which likely define these specifications. The reported performance is qualitative, stating that the device "demonstrated equivalent performance" or was "within specification."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated. The "Accuracy" study mentions "Patient Samples," but the number of samples used is not provided.
Data Provenance: Not explicitly stated. The document describes the device preparing "human whole blood," implying human samples were used, but the country of origin is not mentioned. The studies appear to be prospective, laboratory-based evaluations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The studies listed (Accuracy, Precision, Carryover) are performance assessments of the automated system itself, not studies relying on interpretation by experts to establish a "ground truth" for diagnostic purposes. The ground truth for these types of studies would likely be objective measurements or comparisons against established manual methods or reference instruments.

4. Adjudication Method for the Test Set:

This information is not provided. As noted above, the studies are performance assessments, not expert-opinion-based diagnostic studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers interpreting diagnostic images or data, and the BD FACS™ Sample Prep Assistant III is an automated sample preparation device, not an interpretive diagnostic tool.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance assessment was done. The studies listed (Accuracy, Precision, Carryover) are evaluations of the device's performance in preparing samples. The "results" section directly refers to the "SPA III" or "SPA III with the BD FACSCalibur system" demonstrating equivalent performance or being within specification, indicating that the device's automated functions were assessed directly.

7. Type of Ground Truth Used:

The type of ground truth used would be based on objective measurements and comparisons against established reference methods.

For Accuracy, the "Method Comparison and Bias Estimation" likely compared results from samples prepared by the SPA III to results from samples prepared by a predicate device or a manual, gold-standard method.
For Precision, the ground truth would be statistical measures of reproducibility and repeatability based on replicate measurements.
For Carryover, the ground truth would be the absence or minimal presence of analytes from a high-concentration sample in a subsequent low-concentration sample, measured objectively.

8. Sample Size for the Training Set:

This information is not applicable or not provided. The BD FACS™ Sample Prep Assistant III is an automated pipetting and diluting system. It is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on pre-programmed protocols and mechanical precision, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as the device does not utilize a training set in the context of AI/machine learning. Its "ground truth" for operational accuracy and precision would be established through engineering specifications, calibration, and validation against known standards during its development and manufacturing.

Summary

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Section 5: 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is K131301

1.0	Submitted By:	BD Biosciences2350 Qume DriveSan Jose, CA 95131 USA
	Contact:	Kimberly LiedtkeRegulatory Affairs SpecialistTelephone: 408.954.4149Email: Kimberly_Liedtke@BD.com
	Date Prepared:	August 1, 2013
2.0	Device Name:	BD FACS™ Sample Prep Assistant III
	Classification:	Class II (21 CFR 864.5220 - Automated DifferentialCell Counter)

3.0 Intended Use: The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

4.() Indications for Use:

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Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems:

BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
BD Multitest IMK Kit with or without BD Trucount Tubes .
BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with . or without BD Trucount Tubes
BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without . BD Trucount Tubes

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur flow cytometry systems:

BD Multitest IMK Kit with or without BD Trucount Tubes .
BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with . or without BD Trucount Tubes
BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without . BD Trucount Tubes
BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .

For in vitro diagnostic use.

Basic Description of the Device: 5.0

The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow

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cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.

Predicate Device: 6.0
The BD FACSCalibur system, using the BD FACS™ Sample Prep Assistant III (SPA III) is substantially equivalent to the BD FACSCanto II system using the BD FACS™ Sample Prep Assistant III (SPA III). For both systems, the SPA III is used to prepare human whole blood for flow cytometric analysis. When used with the BD FACSCalibur system, the SPA III and manual pipetting are used for the same sample type and result in similar performance characteristics.
Comparison to the Predicate: 7.0
Similarities and Differences:

Characteristic	BD SPA III used with theBD FACSCanto II system(predicate)	BD SPA III used with theBD FACSCanto II andBD FACSCalibur systems(modification)
Intended Use	The BD FACS™ SamplePrep Assistant III isintended to prepare humanwhole blood for flowcytometric analysis on BDFACSCanto II flowcytometry systems.	The BD FACS™ SamplePrep Assistant III isintended to prepare humanwhole blood for flowcytometric analysis on BDFACSCanto II and BDFACSCalibur flowcytometry systems.
Sample Type	Whole blood	Same

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PreparationMethod	Automated	Same
PipettingSyringe	1 mL sample/reagentsyringe10 mL lyse syringe	Same
Supportedprimaryblood sampletubes	VacutainerSarstedt	Same
Probe Rinse	3 pulses of approximately 1second	Same
Single-dispenseexcess drawnreagent(waste)	4 µL	Same

And Children Children

8.0 Summary of Performance Data

Study	Study Design	Results
Accuracy	Based on MethodComparison and BiasEstimation Using PatientSamples; ApprovedGuideline, CLSI documentEP9-A2	The SPA III with the BDFACSCalibur systemdemonstrated equivalentperformance in its ability toprepare human whole bloodfor flow cytometricanalysis.
Precision	Based on Evaluation ofPrecision Performance ofClinical Chemistry Devices;Approved Guideline, CLSIdocument EP5-A2	The SPA III demonstratedsystem precision withinspecification.
Carryover	Based on recommendationscontained in Class IISpecial Controls GuidanceDocument: PremarketNotifications for AutomatedDifferential Cell Countersfor Immature or AbnormalBlood Cells; FinalGuidance for Industry andFDA, December 4, 2001	The SPA III demonstratedsystem carryover withinspecification.

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The BD FACS™ Sample Prep Assistant III with the BD FACSCalibur system demonstrates substantial equivalence to the predicate method.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble a person embracing or supporting another, representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 2, 2013

BD BIOSCIENCES C/O MS. KIMBERLY LIEDTKE REGULATORY AFFAIRS SPECIALIST 2350 QUME DRIVE SAN JOSE, CA 95131

Re: 510(k) Number:	K131301
Trade/Device Name:	BD FACS™ Sample Prep Assistant III
Regulation Number:	21 CFR 862.2750
Regulation Name:	Pipetting and Diluting System for Clinical Use
Regulatory Class:	Class I
Product Code:	PER
Dated:	May 2, 2013
Received:	May 7, 2013

Dear Ms. Liedtke:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kimberly Liedtke

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): _K131301

Device Name: BD FACSTM Sample Prep Assistant III_

Intended Use:

The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

Indications for Use:

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems:

BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
BD Multitest IMK Kit with or without BD Trucount Tubes .
BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems:

BD Multitest IMK Kit with or without BD Trucount Tubes .
BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .

For in vitro diagnostic use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________	And/Or	Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR Part 801 Subpart D)		(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Maria M. Chan -S

Division Sign-Off

Regulation Number and Section

§ 862.2750 Pipetting and diluting system for clinical use.

(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.